"80425-0343-1" National Drug Code (NDC)

Ramelteon 30 TABLET, FILM COATED in 1 BOTTLE (80425-0343-1)
(Advanced Rx Pharmacy of Tennessee, LLC)

NDC Code80425-0343-1
Package Description30 TABLET, FILM COATED in 1 BOTTLE (80425-0343-1)
Product NDC80425-0343
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRamelteon
Non-Proprietary NameRamelteon
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20230615
Marketing Category NameANDA
Application NumberANDA213815
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
Substance NameRAMELTEON
Strength8
Strength Unitmg/1
Pharmacy ClassesMelatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]

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